Expert: Specialty Drug Pipeline Remains Robust, With Exciting New Drugs On the Horizon


Approximately 43 total specialty drugs come to the market each year, on average.

In an interview with Pharmacy Times at the 2023 Asembia Specialty Pharmacy Summit, Ray Tancredi, MBA, divisional vice president of Specialty Pharmacy Development and Brand Rx/Vaccine Purchasing at Walgreens, discussed the landscape of CAR T therapies, immunotherapies, and gene therapies in the market and the pipeline.

Q: What are the impacts of CAR T therapy, immunotherapy, and gene therapy drugs in the market?

Ray Tancredi, MBA: Yeah, [they are] very interesting products. They use the patient's own T cells from the bone marrow. I think there are 6 products that are CAR T in the marketplace today. Most of them or all of them are for cancers, whether it's large beta cell lymphoma, multiple myeloma, and leukemias. I look at 2 more products potentially entering the market over the next the next few months. I think there's one called ALLO-501 for multiple myeloma. I think there's a product for acute lymphocytic leukemia. And there's also UCART123 for AML. So, it continues to evolve. Like I said, there's 6 products. They used to be the products of last resort. However, last year, Yescarta got approved after one treatment failure for large beta cell lymphoma. So that usage is evolving and progressing over time. And we continue to see products in the pipeline for CAR T.

Q: What significant drugs are still in development that pharmacists should be aware of?

Ray Tancredi, MBA: Yeah, there's so many. I did a presentation yesterday and I had 85 drugs in my presentation. I didn't get to all of them. But there are a number that are that are really interesting. You have zuranolone, which is for postpartum depression and major depressive disorder, which could be an interesting product. You have a number of gene and cell products—you have SRP-9001 for Duchenne muscular dystrophy [which] really meets an unmet need. It will be the first gene cell product for Duchenne muscular dystrophy. You'll also have velocigene roxaparvovec; it'll be for severe hemophilia A. Again, that meets an unmet need. So, we continue to evolve with those products, and it's a subset of the overall hemophilia A population. But it'll bring a new product and a new choice to the marketplace.

Q: Are there any other notable findings you would like to touch on?

Ray Tancredi, MBA: Yeah, the FDA pipeline for specialty has been remarkably consistent over the years. You're looking at an average of about 43 total drugs coming to market each and every year, being approved by the FDA. Even in oncology, I know we had a slow start to the year in oncology with only 2 drugs being approved in 2023 so far, but the pipeline is deep. You know, when I did some research, I saw that there's 25 drugs that have NDAs filed, and if you count preclinical trials, there's about 4800 oncology products that are that are poised to be reviewed through the FDA process, and 2500 of those are in phases 1 through 3. So, the oncology pipeline remains robust. And the specialty pipeline—that includes rare and orphan, oncology, cell and gene, and traditional specialty drugs—remains robust as well.

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